DETAILED CORRESPONDENCE
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in response to the papers filed January 29, 2026. Currently, claims 1, 5-18 are pending.
All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow. This action is made FINAL.
Any objections and rejections not reiterated below are hereby withdrawn.
The 102 rejection over Hollenbach has been withdrawn in view of the Saper Declaration filed January 29, 2026.
Priority
This application claims priority to
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Drawings
The drawings are acceptable.
Claim Rejections - 35 USC § 112- Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 5-9, 15-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
A) Claims 1, 5-9, 15-18 are directed to administering an “alternative therapy may comprise one or more therapies selected from…” to the subject. The claim is unclear what the alternative is since it may or may not be from the list. Claim 10 requires the alternative therapy to be one of the same alternative therapies. Thus, it is unclear what Claim 1 requires since Claim 10 requires the same therapies. If Claim 1 is amended to require a therapy selected from the list, Claim 10 would not further limit Claim 1. Thus, it is not clear what alternative encompasses. Clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim(s) 1, 9-11, 15, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chibout et al. (US 2005/0032062, February 10, 2005).
Chibout teaches measuring the level of mRNA of HLA-DRB1*1502 in a patient who has or is suspected of having sarcoidosis and treating with immunosuppressive therapy.
With respect to Claims 9-11, 18, the immunosuppressive therapy could include corticosteroids, cyclosporine, methotrexate, azathioprine, clorambucil (para 60).
With respect to Claim 15 the subject has sarcoidosis which is an inflammatory disease characterized by the growth of tiny, abnormal cell clumps in organs.
Claim(s) 1, 5, 9-11, 15, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sugimori et al. (Experimental Hematology, Vol. 35, Pages 13-20, 2007).
Sugimori teaches genotyping HLA-DRB1 alleles, namely DRB1*1501 and 1502 and treating with ATG plus cyclosporin (CsA) therapy. Sugimori teaches administration of cyclospoin A (CsA) to patients with DRB1*1501 improves hematopoietic function (page 13, col. 2).
Conclusion
No claims allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Frank (US 2012/0121513, March 17, 2012). Frank teaches genotyping the DLA DRB1*15 allele in canines to detect the allele and administering cyclosporin A (para 123). Frank teaches detecting DLA rather than HLA.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng (Winston) Shen can be reached on (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
April 3, 2026